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Epilepsy Neurotechnology trials

Evaluation of the Epilepsy-related Quality of Life, Seizure-related Accidents and Validation of the Mjn-SERAS Solution in the Normalised Patient Environment with Real-World Data

RecruitingNCT05845255Phase: Not specifiedStarted 2023-05-01

Summary

The study will be prospective, multicentre, postmarketing clinical study, with a controlled and randomized design, to perform the analysis of 130 subjects with a clinical diagnosis of epilepsy, patients whose clinical semiology of their epilepsy is considered to be of interest for the validation in the day-to-day life a medical device (mjn-SERAS), which has already been validated and certified in Europe with CE mark Class IIa. This new validation will take place in the participant's normalised

Eligibility

Sex
ALL
Min Age
12 Years
Max Age
65 Years

Inclusion Criteria: * Age criterion: o Patient must be 12 to 65 years of age inclusive, at the time of signing the informed consent. * Clinical criteria: * Confirmed diagnosis of drug-resistant\*1 epilepsy, with focal, generalized or focal -generalized seizures, according to international sta

Locations

Diakonie Kork
Kork, Germany
Clínica Corachan
Barcelona, Barcelona, Spain
CUN
Madrid, Madrid, Spain
Vithas La Milagrosa
Madrid, Madrid, Spain
CUN
Pamplona, Navarre, Spain

Interested in participating? View the full study details on ClinicalTrials.gov:

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